CQV Engineer - Labs

EFOR; Zuid-Holland; On-site; EUR 60,000 - 90,000; Full time

Job summary

EFOR is seeking a CQV Engineer for Lab Equipment to plan, coordinate, and execute qualification activities in a cGMP setting. You will lead IQ/OQ/PQ for HPLCs, GCs, balances, incubators, and related systems, leveraging Kneat to manage documentation and workflow.

You will ensure data integrity, participate in risk assessments, and support regulatory inspections with CQV SME input. The role emphasizes cross-functional collaboration with QA, vendors, and lab users in a GMP environment.

Qualifications

• 5+ years’ CQV/Validation experience in pharma/biotech.
• Experience with lab equipment and analytical systems.
• Knowledge of GMP, GAMP, ICH, USP and data integrity.

Responsibilities

• Lead/perform CQV activities (IQ/OQ/PQ) for laboratory equipment (HPLCs, GC, balances, incubators, centrifuges, autoclaves, environmental chambers).
• Develop, review, and execute validation protocols and documentation using Kneat.
• Manage CQV documentation lifecycle (creation, routing, storage, retrieval) in Kneat.
• Coordinate with vendors, QA, lab users and stakeholders during FAT/SAT, installation and qualification.
• Review equipment design, installation, and system suitability as part of qualification.
• Document commissioning and qualification test scripts, investigate deviations, support CAPA.
• Ensure instruments are calibrated and in lifecycle compliance.
• Maintain validation master plans, schedules, and equipment lists using Kneat.
• Participate in project design reviews and provide CQV input for new equipment.
• Serve as CQV SME during inspections and audits.
• Propose process improvements related to qualification, data integrity and compliance.
• Ensure compliance with FDA, EMA and other regulatory guidance.

Skills

CQV / Validation expertise

Laboratory equipment know-how

Regulatory compliance

Audit readiness

Education

Bachelor's degree or higher in Engineering or Sciences

Tools

Kneat

Job description

The CQV (Commissioning, Qualification, and Validation) Engineer for Lab Equipment is responsible for planning, coordinating, and executing CQV activities associated with laboratory equipment in a pharmaceutical manufacturing or QC laboratory environment. The role ensures that all lab assets are fully qualified, compliant with regulatory standards, and fit for purpose within a cGMP framework. The engineer will utilize electronic validation platforms such as Kneat to efficiently manage documentation and workflow.

Key Responsibilities:

• Lead and/or support the commissioning, qualification (IQ/OQ/PQ), and validation of laboratory equipment such as HPLCs, UPLCs, GCs, balances, incubators, centrifuges, autoclaves, environmental chambers, and other analytical systems.
• Develop, review, and execute validation protocols, risk assessments, supporting technical documentation, deliverables, and final reports using Kneat or similar electronic validation systems; ensure alignment with cGMP and internal quality systems.
• Manage the end-to-end CQV documentation lifecycle (creation, routing, approval, storage, retrieval) within Kneat, maintaining data integrity and audit readiness.
• Coordinate with equipment vendors, contractors, quality assurance, lab users, and other stakeholders during the project lifecycle, including FAT, SAT, installation, qualification, and troubleshooting.
• Review and assess equipment design, installation, and system suitability as part of the qualification process.
• Execute and document commissioning and qualification test scripts, investigate deviations, and support non-conformance resolution, all within Kneat.
• Ensure all instruments and equipment are correctly calibrated, maintained, and compliant through their lifecycle.
• Maintain and update equipment validation master plans, project schedules, status trackers, and equipment lists utilizing Kneat where applicable.
• Participate in project planning and design reviews, providing CQV input for new equipment or lab upgrades.
• Serve as CQV SME (Subject Matter Expert) for lab equipment and electronic validation tools during regulatory inspections and audits.
• Propose and implement process improvements related to equipment qualification, data integrity, and regulatory compliance.
• Ensure compliance with relevant regulations, such as FDA, EMA, and other regional/international guidance.
• Support Data Integrity and ALCOA+ principles, focusing on system controls and record-keeping via Kneat.

Key Requirements:

• Bachelor’s degree or higher in Engineering, Sciences, or a closely related discipline.
• Minimum of 5 years’ CQV/Validation experience in the pharmaceutical or biotechnology industry, with a significant focus on laboratory equipment.
• Extensive working knowledge of GMP, GAMP, ICH, USP, data integrity requirements, and relevant regulatory guidelines for laboratory systems.
• Demonstrable experience working with Kneat or similar electronic quality/document management systems for validation lifecycle management.
• Proven experience developing and executing IQ/OQ/PQ protocols and managing deviations and change controls, ideally leveraging an electronic system such as Kneat.
• Strong understanding of laboratory workflows, analytical technologies, and system interfaces (including computerized systems).